Which Congressional bills have been proposed since 2000 to require mandatory reporting or product listing for dietary supplements, and what became of them?
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Executive summary
Since 2000 Congress has repeatedly proposed two types of mandates for dietary supplements—mandatory adverse-event reporting and mandatory product listing/registration with FDA—but none of the standalone listing laws became permanent federal statute in the sources provided, while multiple reporting bills repeatedly reached committee consideration without clear evidence of final enactment in the provided records [1] [2] [3] [4] [5].
1. The recurring theme: reporting and listing bills after DSHEA
After the Dietary Supplement Health and Education Act of 1994 left the market largely unlisted and decentralized, lawmakers returned repeatedly to two fixes: require manufacturers to report serious adverse events to FDA, and require companies to list products and ingredients with FDA so the agency can see what is on the market; Congressional Research Service summaries and floor materials document numerous post-1994 proposals across the 2000s and 2010s aimed at these goals [1] [2].
2. Mandatory adverse-event reporting: multiple attempts, stalled enactment
Senator Dick Durbin’s S.722 in the 108th Congress sought to amend the FD&C Act to require manufacturers to submit reports on adverse experiences and to define “serious adverse dietary supplement experience,” including hospitalization, death, or birth defects, and to reduce duplicative reporting burdens by allowing packers or distributors to forward reports to manufacturers for transmission to FDA [3]. Related House measures—such as H.R.4747 in the 108th Congress—also would have required manufacturers and distributors to report serious adverse experiences and to establish reporting systems [6]. Committee reports like S. Rept. 109-324 show the Senate considered mandatory serious adverse event reporting regimes (S.3546) and described how such a framework would supersede voluntary systems like CAERS [4]. The sources show committee consideration and explanatory reports but do not document final enactment of these standalone reporting bills into law within the cited material; the CRS and congressional bill pages indicate referral and reporting activity but not statutory completion in the provided excerpts [3] [4] [6].
3. Product listing/registration: renewed momentum in the 2020s
Legislative energy to require product listing re-emerged in the 2020s. The Senate Dietary Supplement Listing Act (S.4090) in the 117th Congress would have required responsible persons to register each dietary supplement with FDA, provide ingredient lists, conditions of use, warnings, claims, contact information, and manufacturing locations, and would have compelled FDA to create a unique identifier and public database [5]. The 118th Congress carried follow-ups: S.4827 (Dietary Supplement Listing Act of 2024) and Senate press and sponsor statements indicate Durbin and others reintroduced listing legislation to force transparency because DSHEA originally did not require market registration [7] [8]. The govinfo text for a Braun-sponsored Senate bill similarly describes an amendment to the FD&C Act to require manufacturers to list dietary supplements with FDA and sets timelines for existing and discontinued products [9]. The provided sources document introductions, summaries, and press releases but do not present evidence that any of these listing bills achieved final enactment within the quoted materials [5] [7] [9].
4. Where the proposals went: committee activity, endorsements, and partial incorporations
Bills repeatedly cleared initial stages: they were introduced, referred to committees, sometimes incorporated in committee reports or user-fee negotiation drafts, and earned endorsements from a mix of consumer and industry groups; for example, a modified Durbin–Braun proposal was reported as included in a HELP Committee draft user-fee package, and sponsors noted backing from advocacy and professional organizations [10]. Congressional reports like S. Rept. 109-324 describe how proposed mandatory reporting would replace voluntary CAERS reporting [4]. But the documentary trail in these sources shows that most measures remained at the committee or drafting stage rather than becoming permanent law in the texts provided [4] [10] [5].
5. Bottom line and limits of available records
The legislative record since 2000 includes multiple specific bills to require adverse-event reporting (e.g., S.722, H.R.4747, S.3546-related work) and to require product listing/registration (e.g., S.4090, S.4827 and related sponsorship materials), and several advanced to committee consideration or were folded into committee drafts, but the materials provided do not document final enactment of a standalone, permanent statutory product-listing regime; where the sources are silent on a bill’s final disposition, this analysis does not assert outcomes beyond what the cited documents show [3] [6] [4] [5] [7].